NCT00003691已完成3 期
A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 145
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
详细描述
OBJECTIVES:
- Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.
- Compare the toxicities of these two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.
Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma
- •Very poor potential for cure by radiotherapy or surgery alone or in combination
- •Measurable disease
- •Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count at least 100,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •SGPT no greater than 3 times upper limit of normal
- •Bilirubin normal
- •Creatinine no greater than 1.6 mg/dL
- •Cardiovascular
- •LVEF at least 50% within past 6 months
- •No uncontrolled angina
- •No third-degree or complete heart block unless a pacemaker is in place
- •No serious peripheral neuropathy
- •No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer
- •No uncontrolled infection
- •No sensitivity to E. coli-derived drug preparations
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior biologic therapy allowed
- •No concurrent biologic therapy
- •Chemotherapy
- •No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization
- •No prior chemotherapy for any prior malignancy
- •Endocrine therapy
- •Prior hormone therapy allowed
- •No concurrent hormone therapy
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine
- •Not specified
排除标准
- 未提供
研究者
研究点 (145)
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